Nephelometer, for Clinical Use

Who Makes This Device Type in China?

2 manufacturers in China hold an FDA registration for this device type, based in Jiangsu and Zhejiang. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer

What Is FDA Product Code JQX?

Nephelometer, For Clinical Use is FDA product code JQX, Class 1, 21 CFR 862.2700.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 4 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Process control (1) and Nonconforming Material/Component (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Nephelometer, For Clinical Use

BD PhoenixSpec™ Calibrator Kit

Catalogue number 440911, listed by Becton, Dickinson AND Company, United States, under Nephelometer, For Clinical Use. 2 manufacturers in China are registered for this product code.

Nephelometer, For Clinical Use

Sensititre Nephelometer

The Sensititre™ Nephelometer is used for standardizing the inoculum density of a bacterial suspension. Light from an ultrabright light emitting diode (LED) is scattered by bacteria in…

Nephelometer, For Clinical Use

BD PhoenixSpec™ Nephelometer

Catalogue number 440910, listed by Becton, Dickinson AND Company, United States, under Nephelometer, For Clinical Use. 2 manufacturers in China are registered for this product code.

Nephelometer, For Clinical Use

BD Phoenix™ AP

Catalogue number 448010, listed by Becton, Dickinson AND Company, United States, under Nephelometer, For Clinical Use. 2 manufacturers in China are registered for this product code.

Nephelometer, For Clinical Use

BD PhoenixSpec™ Calibrator 2.0 McFarland

Catalogue number 441953, listed by Becton, Dickinson AND Company, United States, under Nephelometer, For Clinical Use. 2 manufacturers in China are registered for this product code.

Nephelometer, For Clinical Use

BD PhoenixSpec™ Calibrator 0.50 McFarland

Catalogue number 441356, listed by Becton, Dickinson AND Company, United States, under Nephelometer, For Clinical Use. 2 manufacturers in China are registered for this product code.

Nephelometer, For Clinical Use

BD PhoenixSpec™ Calibrator 0.25 McFarland

Catalogue number 441355, listed by Becton, Dickinson AND Company, United States, under Nephelometer, For Clinical Use. 2 manufacturers in China are registered for this product code.

Nephelometer, For Clinical Use

BD PhoenixSpec™ AP Calibrator Kit

Catalogue number 441951, listed by Becton, Dickinson AND Company, United States, under Nephelometer, For Clinical Use. 2 manufacturers in China are registered for this product code.

Nephelometer, For Clinical Use

Immage

Immage 800

Nephelometer, For Clinical Use

BD Kiestra™ ID AST Calibrator Kit

Catalogue number 444064, listed by Becton, Dickinson AND Company, United States, under Nephelometer, For Clinical Use. 2 manufacturers in China are registered for this product code.

Nephelometer, For Clinical Use

BD BBL™ CrystalSpec™ Calibration Tubes

Catalogue number 245015, listed by Becton, Dickinson AND Company, United States, under Nephelometer, For Clinical Use. 2 manufacturers in China are registered for this product code.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer